Aseptic piercing system and method

ABSTRACT

The present disclosure provides aseptic vial piercing and sterilization systems, and methods of assembling, using and sterilizing same. The systems and methods utilize a pre-sterilized primary container including a first end, a first cavity, a second end with an opening in communication with the first cavity, a septum at least partially sealing the opening, and a product within the first cavity. The systems and methods include an injection assembly including a first end portion of a hollow flowpath forming member. The injection assembly and the primary container may be assembled in a non-sterile environment to form a second cavity extending about the first end portion of the flowpath forming member and to the primary container. The second cavity may then be selectively sterilized in a non-deleterious manner to the product to allow the first end portion to aseptically pierce the septum to extend into the first cavity.

CROSS REFERENCE TO RELATED APPLICATION

This application claims priority benefit under 35 U.S.C. § 119(e) toU.S. Provisional Application No. 62/130,718, filed Mar. 10, 2015, andentitled Aseptic Piercing System and Method, the entirety of which isincorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates generally to delivery systems foradministering medication. More specifically, but not exclusively, thepresent invention concerns aseptic piercing systems.

BACKGROUND OF THE INVENTION

Currently before a needle is introduced into a vial, primary containeror cartridge, it is necessary to use an alcohol wipe to sterilize theface of the vial septum in order to maintain a sterile environment. Ifsterilization of the vial septum is not properly performed, themedication may be contaminated or contaminants may be delivered to thepatient. Further, such wiping is an extra step to perform and it is notpractical if the container is inside a delivery device. Typically,wiping the face of the vial septum also adds another step in thesterilization process.

Thus, an aseptic piercing system that ensures a sterile environmentwithout the risk of contamination is desirable.

SUMMARY OF THE INVENTION

Aspects of the present disclosure provide aseptic vial piercing andsterilization systems. The present disclosure also provides methods forassembling, using and sterilizing the aseptic vial piercing systems.

In one aspect, the present disclosure provides a method of forming anaseptic primary container piercing mechanism. The method includesobtaining a pre-sterilized primary container including a first end, afirst cavity, a second end with an opening in communication with thefirst cavity, a septum at least partially sealing the opening, and aproduct within the first cavity. The method further includes obtainingan injection assembly including a first end portion of a hollow flowpathforming member. The method also includes assembling the injectionassembly with the second end of the primary container in a non-sterileenvironment to form a second cavity extending about the first endportion of the flowpath forming member and to the primary container.Further, the method includes terminally sterilizing the second cavityand the first end portion of the flowpath forming member therein.

In some embodiments, the prior to the terminally sterilizing, the secondcavity and the first end portion of the flowpath forming member may benon-sterile. In some embodiments, terminally sterilizing the secondcavity and the first end portion of the flowpath forming member mayinclude injecting a sterilient through the flowpath forming member andthereby into the second cavity. In some such embodiments, the sterilientmay be introduced into the flowpath forming member via a second endportion of the flowpath forming member positioned exterior to theinjection assembly.

In some other such embodiments, the primary container may include a bootportion that forms the second cavity. In some such embodiments, the bootportion and the septum may be integral. In some other such embodiments,assembling the injection assembly with the second end of the primarycontainer may insert the flowpath forming member through an opening ofthe boot portion that forms a sliding seal about the flowpath formingmember extending therethrough. In some such embodiments, the opening maybe configured to vent positive pressure such that the injectedsterilient flushes out the atmosphere within the flowpath forming memberand the second cavity. In some such embodiments, the method may furtherinclude injecting an inert gas through the flowpath forming member and,thereby into the second cavity to flush out the sterilient from theflowpath forming member and the second cavity.

In some embodiments, the assembly of the injection assembly and theprimary container may be configured such that axial translation of theprimary container toward the first end portion of the flowpath formingmember effectuates the flowpath forming member being driven through theboot member and the septum such that the flowpath forming member extendsthrough the second cavity and the first end portion is positioned withinthe first cavity in fluid communication with the product. In some suchembodiments, the primary container may be axially translated withrespect to the first end portion of the flowpath forming member for adistance to impale the boot member and the septum on the first endportion of the flowpath forming member such that the flowpath formingmember extends through the second cavity and the first end portion ispositioned within the first cavity in fluid communication with theproduct. In some other such embodiments, the primary container may beaxially translated with respect to the first end portion of the flowpathforming member to such an extent that actuation of the injectionassembly is triggered and the injection assembly thereby axially drivesthe flowpath forming member toward the primary container to impale thefirst end portion of the flowpath forming member through the boot memberand the septum such that the flowpath forming member extends through thesecond cavity and the first end portion is positioned within the firstcavity in fluid communication with the product. In some suchembodiments, the actuation of the injection assembly may releasepreloaded energy of a resilient member of the injection assembly toaxially drive a driver member coupled to the flowpath forming member.

In some embodiments, the first end portion of the flowpath formingmember may be sterile and capped with a capping member, and theinjection assembly may include a permeable window in communication withthe second cavity. In some such embodiments, terminally sterilizing thesecond cavity and the first end portion of the flowpath forming membermay include at least one: diffusing a sterilient through the permeablewindow and into the second cavity and thereby into the first endportion; and directing ultraviolet light through the permeable windowand into the second cavity.

In another aspect, the present disclosure provides an aseptic piercingsystem including a sterile primary container and an injection assemblyincluding a flowpath forming member assembled with the primarycontainer. The sterile primary container includes a first end, a firstcavity, a second end with an opening in communication with the firstcavity, a septum at least partially sealing the opening, a productwithin the first cavity, and a boot portion that forms a second cavity.The flowpath member extends through an opening of the boot portion suchthat a first end portion of the flowpath forming member is positionedwithin the second cavity. The opening of the boot portion forms asliding seal about the flowpath forming member. Axial translation of theprimary container toward the first end portion of the flowpath formingmember effectuates relative translation of the first end portion of theflowpath forming member and the boot member and the septum of theprimary container such that the flowpath forming member extends throughthe second cavity and the first end portion is positioned within thefirst cavity in fluid communication with the product.

In some embodiments, the boot portion and the septum may be integral,and the sliding seal may be configured to vent positive pressure withinthe second cavity. In some embodiments, axial translation of the primarycontainer with respect to the first end portion of the flowpath formingmember may impale the boot member and the septum over the first endportion of the flowpath forming member such that the flowpath formingmember extends through the second cavity and the first end portion ispositioned within the first cavity in fluid communication with theproduct.

In some embodiments, a second end portion of the flowpath forming membermay be positioned exterior to the injection assembly within a sealedthird cavity. In some embodiments, the axial translation of the primarycontainer with respect to the first end portion of the flowpath formingmember may actuate the injection assembly to axially drive the flowpathforming member toward the primary container to impale the first endportion of the flowpath forming member through the boot member and theseptum such that the flowpath forming member extends through the secondcavity and the first end portion is positioned within the first cavityin fluid communication with the product. In some such embodiments, theinjection assembly may include a collar fixed to the second end of theprimary container, a driver retainer axially slidably coupled to thecollar, a driver member axially slidably coupled to the driver retainerand fixed to the flowpath forming member, and a resilient memberpositioned between a portion of the driver retainer and the drivermember. In some such embodiments, in a pre-actuated state of the system,the resilient member may exert a preload force on the driver memberacting axially toward the second end of the primary container, andwherein actuation of the injection system releases the preload force ofthe resilient member on the driver member to axially drive the flowpathforming member toward the primary container to impale the first endportion of the flowpath forming member through the boot member and theseptum such that the flowpath forming member extends through the secondcavity and the first end portion is positioned within the first cavityin fluid communication with the product.

These, and other objects, features and advantages of this invention willbecome apparent from the following detailed description of the variousaspects of the invention taken in conjunction with the accompanyingdrawings.

BRIEF DESCRIPTION OF DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of the specification, illustrate embodiments of the presentdisclosure and together with the detailed description herein, serve toexplain the principles of the present disclosure. The drawings are onlyfor purposes of illustrating preferred embodiments and are not to beconstrued as limiting the present disclosure. It is emphasized that, inaccordance with the standard practice in the industry, various featuresare not drawn to scale. In fact, the dimensions of the various featuresmay be arbitrarily increased or reduced for clarity of discussion. Theforegoing and other objects, features and advantages of the presentdisclosure are apparent from the following detailed description taken inconjunction with the accompanying drawings in which:

FIG. 1 is an exploded, perspective view of an aseptic vial piercingsystem, in accordance with an aspect of the present invention;

FIG. 2 is an exploded, side view of the aseptic vial piercing system ofFIG. 1, in accordance with an aspect of the present invention;

FIG. 3 is an assembled, perspective view of the aseptic vial piercingsystem of FIG. 1 with a transparent connector assembly, in accordancewith an aspect of the present invention;

FIG. 4 is a side view of the aseptic vial piercing system of FIG. 3 witha transparent connector assembly, in accordance with an aspect of thepresent invention;

FIG. 5 is a perspective view of the assembled aseptic vial piercingsystem of FIG. 3 with a transparent connector assembly, in accordancewith an aspect of the present invention;

FIG. 6 is an enlarged perspective view of a portion of the aseptic vialpiercing system of FIG. 3, in accordance with an aspect of the presentinvention;

FIG. 7 is an assembled, perspective view of the aseptic vial piercingsystem of FIG. 1 with a transparent window seal, support member,collapsible member, support ring, and impact cushion, in accordance withan aspect of the present invention;

FIG. 8 is a side view of the aseptic vial piercing system of FIG. 7, inaccordance with an aspect of the present invention;

FIG. 9 is a perspective view of the aseptic vial piercing system of FIG.7, in accordance with an aspect of the present invention;

FIG. 10 is an assembled, perspective view of the aseptic vial piercingsystem of FIG. 1, in accordance with an aspect of the present invention;

FIG. 11 is a side view of the aseptic vial piercing system of FIG. 10,in accordance with an aspect of the present invention;

FIG. 12 is a perspective view of the aseptic vial piercing system ofFIG. 10, in accordance with an aspect of the present invention;

FIG. 13 is an enlarged perspective view of a portion of the aseptic vialpiercing system of FIG. 10 showing the collapsible member in a fullyextended position, in accordance with an aspect of the presentinvention;

FIG. 14 is an enlarged perspective view of a portion of the aseptic vialpiercing system of FIG. 10 showing the collapsible member in a collapsedposition, in accordance with an aspect of the present invention;

FIG. 15 is an assembled cross-sectional view of an aseptic vial piercingsystem in a pre-activated state, in accordance with another aspect ofthe present invention;

FIG. 16 is an assembled cross-sectional view of the aseptic vialpiercing system of FIG. 15 in an activated state with a flowpath formingmember aseptically coupled in fluid communication with a primarycontainer, in accordance with another aspect of the present invention;

FIG. 17 is an assembled cross-sectional view of an aseptic vial piercingsystem in a pre-activated state, in accordance with another aspect ofthe present invention;

FIG. 18 is an assembled cross-sectional view of the aseptic vialpiercing system of FIG. 17 in an activated state with a flowpath formingmember aseptically coupled in fluid communication with a primarycontainer, in accordance with another aspect of the present invention;

FIG. 19 illustrates introduction of a sterilent into the flowpathforming member of the aseptic vial piercing system of FIG. 17 afternon-sterile assembly thereof;

FIG. 20 illustrates sterilization of the end portion of the flowpathforming member and the cavity of the boot member of the assembledaseptic vial piercing system of FIG. 17 via the sterilient;

FIG. 21 is an assembled cross-sectional view of an aseptic vial piercingsystem in a pre-activated state, in accordance with another aspect ofthe present invention;

FIG. 22 is an assembled cross-sectional view of the aseptic vialpiercing system of FIG. 21 in an activated state with a flowpath formingmember aseptically coupled in fluid communication with a primarycontainer, in accordance with another aspect of the present invention;and

FIG. 23 illustrates sterile and non-sterile portions of the aseptic vialpiercing system of FIG. 21 and potential post-assembly sterilization ofthe non-sterile portions.

DETAILED DESCRIPTION FOR CARRYING OUT THE INVENTION

Generally stated, disclosed herein is are aseptic vial piercing andsterilization systems. Further, methods of assembling, using andsterilizing the aseptic vial, primary container and/or cartridgepiercing systems are discussed. The systems and methods provide forpiercing of a vial, primary container or cartridge with a flow-pathmechanism (e.g., a needle) under sterile conditions, without having toperform an alcohol wipe and/or to assemble the drug container into thedevice or similar patient/provider interaction to sterilize the piercingsite.

In this detailed description and the following claims, the wordsproximal, distal, anterior, posterior, medial, lateral, superior andinferior are defined by their standard usage for indicating a particularpart of a device according to the relative disposition of the devicewith respect to a body or directional terms of reference. For example,“proximal” means the portion of a device nearest the point ofattachment, while “distal” indicates the portion of the device farthestfrom the point of attachment. As for directional terms, “anterior” is adirection towards the front side of the device, “posterior” means adirection towards the back side of the device, “medial” means towardsthe midline of the device, “lateral” is a direction towards the sides oraway from the midline of the device, “superior” means a direction aboveand “inferior” means a direction below another object or structure.

Referring to the drawings, wherein like reference numerals are used toindicate like or analogous components throughout the several views, andwith particular reference to FIGS. 1-14, there is illustrated an asepticpiercing system 100. The terms “aseptic piercing system,” “aseptic vialpiercing system,” and “aseptic cartridge piercing system” may be usedinterchangeably herein as they essentially refer to an asepticflowpath-forming mechanism (e.g., a needle) piercing system orstructure. The aseptic piercing system 100 includes a primary container,chamber, syringe, vial, or cartridge 102 with a first end 104 and asecond end 106. The primary container or vial 102 may also include acavity 108 opened at the first end 104 and extending toward the secondend 106. The second end 106 may include a neck 110 with a cap 112engaging the neck 110 to close the second end 106 of the primarycontainer or vial 102. A septum 114 may be positioned between theprimary container or vial 102 and the cap 112 to assist with closing thesecond end 106 of the primary container or vial 102 and allow for aneedle 152 (e.g., a staked needle) to be inserted into the primarycontainer or vial 102 via through the septum. The cavity 108 of theprimary container or vial 102 may be sized to receive a piston 116 toclose the first end 104 of the primary container or vial 102 when amedication or fluid is inside of the cavity 108. The piston 116 may alsoassist with delivery of the medication or fluid, as explained furtherbelow. The aseptic piercing system 100 may also include a seal 118. Theseal 118 may be, for example, ring shaped and sized to engage the cap112 and surround the septum 114.

The aseptic piercing system 100 may also include a connector assembly120, as shown in FIGS. 1 and 2. The connector assembly 120 may include aconnector body 122, a support member 140, a needle cover 150, a flowpathforming member or needle 152 (e.g., a staked needle), a collapsiblemember 160, a support ring 162, an aseptic seal 164, and an impactcushion 170. The connector body 122 may include a base portion 124 andat least one coupling member 126. The base portion 124 may include anopening 128, a recess 130, and a window 132. The opening 128 may extendalong the longitudinal axis of the connector body 122 and from a firstend to a second end of the base portion 124. The recess 130 may bepositioned at the first end of the base portion 124. The at least onecoupling member 126 may be, for example, a ring member (not shown) or atleast two bias legs 126. The at least two legs 126 may each include anengagement member 134 for engaging the cap 112 to secure the connectorassembly 120 to the primary container or vial 102. The engagement member134 may be, for example, a protrusion extending inward from the at leasttwo legs 126 towards the center of the connector body 122 and theengagement members 134 may be angled.

The connector assembly 120 may also include at least one sterilizationindicator 136 and a window seal 138, as shown in FIGS. 1-7. Thesterilization indicators 136 may, for example, tell a user if theconnector assembly 120 has been sterilized and is ready for use. Thesterilization indicators 136 may be positioned within the opening 128and positioned such that they are viewable through the window 132. Thewindow seal 138 may be, for example, partially or completely transparentto allow for a user to view within the window 132 and at least a portionof the opening 128 of the base portion 124. The window seal 138 may alsoclose the window 132 to form a sterile environment for the flowpathforming member 152.

The support member 140 may include a base portion 142 and a flangemember 146 at a second end of the base portion 142. The flange member146 may be generally perpendicular to the base portion 142. The supportmember 140 may also include an opening 144 extending from a first end tothe second end. The flange member 146 may be sized to engage the recess130 in the base portion 124 of the connector body 122. The needle cover150 may be, for example, sized to fit into the opening 144 in thesupport member 140. The needle cover 150 may also be, for example,shaped to match the shape of the opening 144, although other shapes thatwould engage the opening 144 are also contemplated. The flowpath formingmember 152 may be partially inserted into the needle cover 150 beforeinjection, as shown in FIGS. 3-9. The flowpath forming member 152 may besized to extend, for example, through the entire connector assembly 120to pass through the septum 114 for injection of the medication or fluidfrom the primary container or vial 102.

With continued reference to FIGS. 1 and 2, the collapsible member 160may be, for example, cylindrical shaped and sized to engage the supportmember 140. Alternatively, the collapsible member 160 may be, forexample, a cylindrical shaped member with cylindrical accordion likeribs extending along at least a portion of the length of the collapsiblemember 160. The flowpath forming member 152 may extend through theentire collapsible member 160. The support ring 162 may be coupled tothe collapsible member 160. An aseptic seal 164 may be placed around theflowpath forming member 152 where the flowpath forming member 152extends out of the collapsible member 160 to assist with maintaining asterile environment within the connector assembly 120. The impactcushion 170 may engage the support ring 162 and the collapsible member160. The impact cushion 170 may restrict forward motion when the primarycontainer or vial 102 is moved forward, while the flowpath formingmember 152 remains stationary, to engage the flowpath forming member 152and collapse collapsible member 160 to cause the flowpath forming member152 to pierce the septum 114.

The aseptic piercing system 100 may also include an injection assembly180, as shown in FIGS. 1-5 and 7-12. The injection assembly 180 mayinclude a tube 182, an injection member 184, and a needle cover 186. Thetube 182 may be coupled to the flowpath forming member 152 at a firstend and the injection member 184 at a second end. The needle cover 186may engage the injection member 184 at an end opposite the tube 182. Theterms “needle cover,” “cap,” “cover” and “shield” may be usedinterchangeably herein as they each refer to a structure used tomaintain a sterile field about, and protect the patient and medicalprofessional from accidentally being stuck by, the injection member 184.The injection member 184 may be, for example, a needle, microneedle,cannula, or the like for a subcutaneous injection or a tube, dispensingneedle, or the like for topical application to the skin, a patch, or thelike.

The aseptic piercing system 100 may be assembled by, for example,inserting at least one sterilization indicator 136 within the opening128 of the connector body 122. A window seal 138 may be secured to theconnector body 122 over the window 132. Next, a support member 140 maybe positioned in the recess 130 of the connector body 122. The flowpathforming member 152 may be coupled to the needle cover 150. Then, thecoupled flowpath forming member 152 and cover 150 may be inserted in theopening 144 in the support member 140 and positioned in the desiredposition. The coupled flowpath forming member 152 and cover 150 may alsobe positioned within the collapsible member 160 that is located aroundthe support member 140. Next, the support ring 162 may be coupled to thecollapsible member 160 to secure the coupled flowpath forming member 152and cover 150 to the connector body 122. An aseptic seal 164 may bepositioned where the flowpath forming member 152 extends through thecollapsible member 160 to prevent any contamination entering from thatopening. The impact cushion 170 may then be positioned over the supportring 162, collapsible member 160, and support member 140. The flowpathforming member 152 may extend through the opening 172 in the impactcushion 170 and be coupled to an injection assembly 180. Next, the firstend of a tube 182 may be coupled to the flowpath forming member 152 andthe second end of the tube 182 may be coupled to an injection member184. The injection member 184 may have a cover 186 positioned on the endopposite the coupled tube 182. Once the connector assembly 120 andinjection assembly 180 are assembled they may be sterilized. Theconnector assembly 120 may be sterilized by, for example, gammasterilization to create a sterilized primary medication passage.

After the connector assembly 120 is sterilized, a seal ring 118 may bepositioned on the cap 112 of the primary container or vial 102 and theat least one coupling member 126 may be inserted over the cap 112 tosecure the connector assembly 120 to the primary container or vial 102.The primary container or vial 102 may be filled with a medication orfluid for injection into a patient. Next, the primary container or vial102 and needle environment under the window 132 need to be sterilized.To allow for sterilization under the window seal 138, the window seal138 may be made of, for example, Tyvek® or other like materials. Theprimary container or vial 102 and connector assembly 120 may then besterilized using ethylene oxide (ETO) sterilization. The ETOsterilization may penetrate the window seal 138 to sterilize the vialface at the second end 106 of the primary container or vial 102, theseal ring 118, needle cover 150, and needle area proper 152.

The method of using the aseptic piercing system 100 may include, forexample, viewing the sterilization indicators 136 to confirm that bothgamma and ETO sterilization have been performed on the aseptic piercingsystem 100. If the indicators 136 confirm that sterilization iscomplete, the cover 186 may be removed from the injection member 184 andcoupling the injection member 184 to a patient. The primary container orvial 102 may then be moved forward and the impact cushion 170 mayrestrict forward movement of the flowpath forming member 152. As theprimary container or vial 102 is moved the collapsible member 160 maycollapse and with the continued forward motion of the primary containeror vial 102 force the flowpath forming member 152 to extend through thefixed cover 150, as shown in FIG. 14. The collapsible member 160 maymove for example a distance “d” as shown in FIG. 13. The distance “d”may be, for example, equal to the distance the flowpath forming member152 needs to be force to pierce the septum 114. Once the staked flowpathforming member 152 penetrates the cover 150 the flowpath forming member152 will pierce the septum 114 of the primary container or vial 102, asshown in FIG. 14. Once the flowpath forming member 152 passes throughthe septum 114 into the primary container or vial 102 a fluid connectionis formed to enable the medication or fluid within the primary containeror vial 102 to flow through the injection assembly 180 and into thepatient.

FIGS. 15 and 16 illustrate an alternative embodiment of an asepticpiercing system generally indicated by reference numeral 200. Asepticpiercing system 200 is similar to the aseptic piercing system 100described above and illustrated in FIGS. 1-14, and therefore likereference numerals preceded by the numeral “2”, as opposed to “1”, areused to indicate like functioning elements. As shown in FIG. 15, theprimary container or vial 202 may contain a drug, medication or otherliquid or liquid like substance in an as-provided or loaded state. Thesystem 200 may be utilized with, or part of, a delivery device thatactuates the system to deliver the contents of the primary container 202to and through the flowpath or flowpath forming member 252 (e.g., astaked needle), and, ultimately, to the patient.

As also shown in FIG. 15, the system 200 may include a piston 216slidably received within the cavity 208 of the primary container 202behind the contents such that the contents are positioned between thepiston 216 and the second end 206 of the primary container 202 (in theas-provided or loaded state). The piston 216 and the interior of theprimary container 202 may form an aseptic or sterile seal that preventspathogens or other contaminants from passing therebetween and into thecontents. The interior of the primary container 202, including theinterior surfaces of the primary container 202, the contents, and theinterior surfaces of the piston may be sterile or aseptic. The piston216 may thereby maintain the sterile nature of the interior of theprimary container 202. In some embodiments, the piston is made fromrubber.

The system 200 may also include a boot or nipple portion 254 positionedat the second end 206 of the primary container 202, as shown in FIG. 15.The boot 254 may include a base portion 255 positioned over (and/or atleast partially under) a cap 212 (e.g., a crimp cap) on the opening atthe second end 206 of the primary container 202, as described above. Asalso discussed above, the cap 212 may couple a septum 214 over and/orwithin the opening at the second end 206 of the primary container 202.As such, the base portion 255 may overlie the septum 214 and the openingof the primary container 202. The assembly of at least the primarycontainer 202, septum 214, cap 212 and boot 254 may be sterilized beforeassembly with other parts of the system (as described further below)such that at least the interior or non-exposed surfaces thereof (otherthan the cavity 257 of the boot as explained further below) which theflowpath forming member 252 will pass through, as explained furtherbelow, are sterile.

As shown in FIG. 15, the boot portion 254 may include a chamber portion256 extending from the base portion 255 in a direction at leastgenerally away from the piston 216. The chamber portion 256 defines acavity or chamber 257, as shown in FIG. 15. The chamber portion 256includes an opening 258 in communication with the cavity 257, as shownin FIG. 15. In some embodiments, the boot portion 254 may be integratedwith the septum 214 (i.e., integral or of one-piece construction). Insome alternative embodiments (not shown), the boot 254 may be providedor initially assembled on the flowpath forming member 252 and notinstalled directly on/with the primary container 202 and/or integratedwith the septum 214. For example, the boot 254 may be provided with asubassembly that is separately sterilized from the primary container202, and assembled with the primary container 202 in a non-sterileenvironment (and potentially non-destructively sterilized afterassembly), as explained further herein with respect to otherembodiments.

As also shown in FIG. 15, a portion of the flowpath forming member 252,such as a needle, tube or the like, may extend through the opening 258of the chamber portion 256 and into the cavity 257 of the boot 254, butnot through the base portion 255. A first tip or end portion of theflowpath forming member 252 may thereby be positioned within the cavity257. The opening 258 may be pre-formed, or the opening 258 may be formedby the penetration of the flowpath forming member 252 through thechamber portion 256. The opening 258 of the chamber portion 256 may forma sterile sliding seal about the flowpath forming member 252 such thatpathogens or other contaminants are prevented from passing therebetweenand into the cavity 257 and the flowpath forming member 252 can axiallytranslate with respect to the boot portion 254 without disrupting thesterile seal therebetween. The cavity 257 may be sterile or aseptic suchthat the inner surfaces of the cavity 257 and the first end of theflowpath forming member 252 is positioned therein are sterile. Asexplained further below with respect to another embodiment, the cavity257 may initially not be sterile, but may be sterilized after the firstend of the flowpath forming member 252 is inserted through the opening258 and into the cavity 257. In alternative embodiments, rather than theboot 254, a convoluted flexible (e.g., rubber) bellows or bladder membermay form the cavity 257 and allow axial translation of the primarycontainer 202 in relation to the first end portion of the flowpathforming member 252 (or vice versa). The flexible member may also seal orform the cavity 254 about the first end portion of the flowpath formingmember 252 after sterilization thereof.

The flowpath forming member 252 may be positionally fixed with respectto the primary container 202 and the components fixed thereto. Stateddifferently, the flowpath forming member 252 may be substantially fixedin space (such as fixed to a device which the system is utilized with),and the primary container 202 and components fixed thereto may bemovable or translatable with respect to the flowpath forming member 252(such as movable or translatable with respect to a device which thesystem is utilized with). For example, the flowpath forming member 252may be fixed to a larger device or system to which the primary container202 is movably attached.

As shown in FIG. 15, the piston 216 may be coupled to a translationmechanism 266 that is configured to axially translate the piston 216with respect to the primary container 202 (and the components coupledthereto) towards the second end 206. The translation mechanism may beany mechanism effective to selectively axially translate the piston 216with respect to the primary container 202 (and the components fixedthereto) towards the second end 206. As shown in FIG. 16, axial movementof the piston 216 with respect to the primary container 202 (and thecomponents fixed thereto) causes the piston 216 to act against thecontents (e.g., drug, medication). The system 200 design and/or frictionof the piston 216 with the primary container 202 allows or dictates thatthe primary container 202 will move axially more easily than the piston216 such that the primary container 202 will axially translate first viathe translation mechanism 266. As an example, the axial movement of thepiston 216 may try to compress the contents of the primary container202, and, thereby, transfer the axial forces against the second end 206of the primary container to axially translate the primary container 202and the components fixed thereto.

As shown in FIG. 16, the translation mechanism 266 may axially translatethe piston 216, and thereby the primary container 202 and the componentsfixed thereto, to such a degree such that the first end portion of thestationary or fixed flowpath forming member 252 pierces and penetratesor extends through the base portion 255 of the boot 254, the septum 214,and the cavity 208 of the primary container 202, and thereby into fluidcommunication with the contents of the primary container 202. Stateddifferently, the translation mechanism 266 may axially translate thepiston 216, and thereby the primary container 202 and the componentsfixed thereto, to such a degree such that the base portion 255 of theboot 254 is impaled on the first end portion of the stationary or fixedflowpath forming member 252 such that the flowpath forming member 252extends through the septum 214 and into the cavity 208 of the primarycontainer 202 and thereby into fluid communication with the contentsthereof. In some embodiments, the system 200 may be configured suchthat, after activation, no more of the flowpath forming member 252 thanthe portion thereof that was positioned within the sterile cavity 257 ofthe chamber portion 256 pre-activation extends into the cavity 208 ofthe primary container 202. Axial movement of the primary container 202via the piston 216 and axial translation mechanism 266 therebyeffectuates sterile coupling of the flowpath forming member 252 with thecavity 208 of the primary container 202 (and the contents therein). Thisleaves the primary container 202 intact until use, giving the contentswithin the cavity 208 of the primary container 202 better stability instorage and prevents leak out the flowpath forming member 252 beforeuse.

Once the first end portion of the flowpath forming member 252 extendsinto the cavity 208 of the primary container 202 and, thereby into fluidcommunication with the contents thereof, further axial translation ofthe primary container 202 and the components fixed thereto via thetranslation mechanism 266 may be prevented. For example, the device orsystem into which the system 200 is installed may include a stopconfigured to only allow limited axial translation of the primarycontainer 202. As such, as shown in FIG. 16, further axial translationof the piston 216 via the translation mechanism 266 after the first endportion of the flowpath forming member 252 extends into the cavity 208of the primary container 202 and thereby into fluid communication withthe contents thereof forces the contents within the primary container202 through the flowpath formed by the flowpath forming member 252. Asnoted above, the flowpath forming member 252 may be configured to,ultimately, deliver the contents to a patient as a subcutaneousinjection or topical application, for example.

The translation mechanism 266 may effectuate or accomplish axial motionof the piston 216, and thereby axial translation of the primarycontainer 202 and pumping of the contents of the cavity 208 through theflowpath forming member 252, via any mode or method. For example, theexemplary embodiment illustrated in FIGS. 15 and 16 includes a leadscrewmechanism coupled to the back side of the piston 216 that extendsaxially upon relative rotation about the axis. The base of the leadscrewmechanism may be positionally fixed or stationary to effectuate movementof the piston 216. In another exemplary embodiment (not shown), thetranslation mechanism 266 may include a manually engageable surface ormember that is manually manipulated by a user to axially translate thepiston 216. For example, the system 200 may include a cartridge or aplunger coupled to the back side of the piston 216 that is manuallyengaged and axially translated to axially translate the piston 216. Inanother exemplary embodiment (not shown), the translation mechanism 266may include a pneumatic or hydraulic drive member that is actuated orinitiated by a user that provides for axial translation of the primarycontainer 202 and axial translation of the piston 216 with respect tothe primary container 202. The pneumatic or hydraulic drive member mayutilize pneumatic or hydraulic forces to axially translate the drivemember. The drive member may be in the form of expanding bellows, anexpanding bladder, an expanding diaphragm or a sliding seal or piston,for example. The drive member may allow for or provide the axialtranslation of the primary container 202, and the direct pneumatic orhydraulic pressure may axial translation the piston 216.

FIGS. 17-20 illustrate an exemplary alternative embodiment of an asepticpiercing system generally indicated by reference numeral 300. Exemplaryaseptic piercing system 300 is similar to the exemplary aseptic piercingsystem 100 described above and illustrated in FIGS. 1-14 and theexemplary aseptic piercing system 200 described above and illustrated inFIGS. 15 and 16, and therefore like reference numerals preceded by thenumeral “3”, as opposed to “1” or “2”, are used to indicate likefunctioning elements. As shown in FIG. 17, the configuration of theprimary container 302, the contents therein, the piston 316, thetranslation mechanism 366, the cap 312, the septum 314, and the boot 354of the aseptic piercing system 300 may be substantially the same as thatof the aseptic piercing system 200 described above and illustrated inFIGS. 15 and 16. The aseptic piercing system 300 of FIGS. 17 and 18 maydiffer from the aseptic piercing system 200 of FIGS. 15 and 16 in themode of sterile coupling the flowpath forming member 352 with the cavity308 of the primary container 302.

As shown in FIGS. 17 and 18, rather than impaling the base portion 355of the boot 354 and the septum 314 into and through the end portion ofthe flowpath forming member 353 (i.e., translating the primary container302 with respect to the stationary or fixed flowpath forming member 353)as described above with respect to the aseptic piercing system 200 ofFIGS. 15 and 16, the aseptic piercing system 300 drives the end portionof the flowpath forming member 353 into and through the base portion 355of the boot 354 and the septum 314 and into the cavity 308 of theprimary container 302 and thereby into fluid communication of thecontents therein (i.e., translating the flowpath forming member 353 withrespect to the stationary or fixed primary container 302).

As shown in FIGS. 17 and 18, the aseptic piercing system 300 includes acollar 390 coupled or fixed to the second end 306 of the primarycontainer 302. The collar 390 may include a plurality ofcircumferentially spaced fingers 392 engaging and surrounding the neckregion 310 of the primary container 302. In this way, the collar may befixed to the second end 306 of the primary container 302. However, thecollar 390 may be otherwise coupled to the second end 306 of the primarycontainer 302. The collar 390 may include an axially extended wallportion 391 that extends at least partially about the neck region 310,the opening of the second end 306, the cap 312, the septum 314 and/orthe boot 354. The wall portion 391 of the collar 390 may be positionedradially or laterally outward of the neck region 310 and/or extendaxially past the neck region 310, cap 312 and septum 314. The wallportion 391 of the collar 390 may also extend axially past at least aportion of the boot 354, such as past the base portion 355 and partiallypast the chamber portion 356, as shown in FIGS. 17 and 18.

In the pre-activated state of the system 300 as shown in FIG. 17, atleast one engagement portion or distal axial edge 393 of the collar 390may engage a corresponding at least one radially or laterally inwardlyextending cam, latch or actuation portion 394 of a driver retainermember 395. The retainer member 395 may be axially slidably ortranslatably coupled to the collar 390. The collar 390 and retainermember 395 may be configured such that in the pre-activated state orarrangement shown in FIG. 17, at least a portion of the cam or actuationportion 394 of the retainer member 395 is positioned axially directlybehind a retaining portion 399 of a driver member 398 axially slidablyor translatably coupled within the retainer member 395. As shown in FIG.17, a flowpath engaging portion 391 of the driver member 398 may extendaxially into and through an axial end cap portion 396 of the retainermember 395 and into an interior portion of the retainer member 395, andthe retaining portion 399 of the driver member 398 may extend from theflowpath engaging portion 391. In some embodiments, the flowpathengaging portion 391 of the driver member 398 may be substantiallycylindrical and the retaining portion 399 of the driver member 398 maybe a flange extending about an axial end of the flowpath engagingportion 391, as shown in FIG. 17.

As also shown in FIG. 17, in the pre-activated state of the system 300an elastically deformed biasing or resilient member 397 may bepositioned axially between the cap portion 396 of the retainer member395 and the retaining portion 399 of a driver member 398. The biasingmember 397 may thereby exert a preloaded axial force against the drivermember 398 in the pre-activated state of the system 300 acting in thedirection towards the primary container 302. The biasing member 397 maybe any member effective in applying the axial preloaded force in thepre-activate state, and then releasing such preloaded force uponactivation, as discussed below with reference to FIG. 18. In someembodiments, the biasing member 397 may be a spring.

The flowpath forming member 352 may be fixed or coupled to the drivermember 398 such that the flowpath forming member 352 axially slides ortranslates with the driver member 398. As discussed above, in thepre-activated state of the system 300 the first end portion of theflowpath forming member 352 may be positioned within the sterile cavity357 of the chamber portion 356 of the boot 354, but not through the baseportion 355 of the boot 354, the septum 314 and/or into the cavity 308of the primary container. As shown in FIG. 17, the first end portion ofthe flowpath forming member 352 may be axially spaced from the baseportion 355 of the boot 354 in the pre-activated state.

The assembly of the driver member 398, flowpath forming member 352,biasing member 397 and driver retainer member 395 may be axially fixedduring the pre-activation state of the system 300 and upon activationprior to release of the driver 398, as explained further below. Stateddifferently, the driver member 398, flowpath forming member 352, biasingmember 397 and driver retainer member 395 may be substantially axiallyfixed in space (such as fixed to a device with which the system 300 isutilized), and the primary container 302 and components fixed theretomay be axially movable or translatable with respect to the driver member398, flowpath forming member 352, biasing member 397 and driver retainermember 395 (such as movable or translatable with respect to a devicewith which the system is utilized) during the pre-activation state ofthe system 300 and upon activation prior to release of the driver 398.For example, the driver member 398, flowpath forming member 352, biasingmember 397 and driver retainer member 395 may be axially fixed to alarger device or system to which the primary container 302 (and thecomponents fixed thereto) is movably attached.

When the system 300 is activated as shown in FIG. 18 (and in comparisonto FIG. 17), the translation mechanism 366 may be initiated or activated(as discussed above) to axially translate the piston 316 towards thesecond end 306 of the primary container 302. As discussed above, suchaxial movement of the piston 316 within the cavity 308 of the primarycontainer 302 will act to compress the contents within the cavity 308and, ultimately, axially translate the primary container 302 and thecomponents fixed thereto in an axial direction extending from the firstend 304 to the second end 306. Upon activation of the system 300 asshown in FIG. 18, the translation mechanism 366 may axially translatethe primary container 302 to such an extent that the at least oneengagement portion 393 of the collar 390 engages and radially orlaterally deflects or translates the at least one cam or actuationportion 394 of the driver retainer member 395 out from axially behindthe retaining portion 399 of the driver member 398. In this way, theretaining portion 399 of the driver member 398 is then able to clear theat least one cam or actuation portion 394 of the driver retainer member395 and allow the preloaded force of the biasing member 397 to axiallytranslate the driver 398, and the flowpath forming member 352 fixedthereto, towards the second end 306 of the primary container 302.

It is noted that the system 300 may be configured such that the axialtranslation of the primary container 302 and collar 390 to release theat least one cam or actuation portion 394 may not act to cause the firstend portion of the flowpath forming member 352 to pierce and/or extendthrough the base portion 355 of the boot 354 and/or the septum 314. Forexample, in the pre-activated state the first end portion of theflowpath forming member 352 may be sufficiently axially spaced from thebase portion 355 of the boot 354 and/or the septum 314 such that theaxial translation of the primary container 302 and collar 390 to releasethe at least one cam or actuation portion 394 does not act to cause thefirst end portion of the flowpath forming member 352 to pierce and/orextend through the base portion 355 of the boot 354 and/or the septum314.

As shown in FIG. 18, axial translation of the driver 398 and theflowpath forming member 352 toward the second end 306 of the primarycontainer 302 causes the first end portion of the flowpath formingmember 352 to pierce and penetrate or extend through the base portion355 of the boot 354, the septum 314, and the cavity 308 of the primarycontainer 302, and thereby into fluid communication with the contents ofthe primary container 302. Stated differently, the translation mechanism366 may axially translate the piston 316, and thereby the primarycontainer 302 and the components fixed thereto such as the collar 390,to such a degree such that driver 398 is “released” and impales the boot354 and septum such that the flowpath forming member 352 extends intothe cavity 308 of the primary container 302 and thereby into fluidcommunication with the contents thereof. In some embodiments, the system300 may be configured such that, after activation, no more of theflowpath forming member 352 than the portion thereof that was positionedwithin the sterile cavity 357 of the chamber portion 356 pre-activationextends into the cavity 308 of the primary container 302. Axial movementof the driver 398 and flowpath forming member 352 thereby effectuatessterile coupling of the flowpath forming member 352 with the cavity 308of the primary container 302 (and the contents therein). This leaves theprimary container 302 intact until use, giving the contents within thecavity 308 of the primary container 302 better stability in storage andprevents leaks out the flowpath forming member 352 before use.

The biasing member 397 may be configured such that the flowpath formingmember 352 impales the boot 354 and/or septum 314 at a substantiallyhigh speed, such as at least about 10 mm/sec. In some embodiments, thebiasing member may be configured such that the flowpath forming member352 impales the boot 354 and/or septum 314 at about 40 mm/sec. Therelatively quick piercing of the boot 354 and/or septum 314 via thebiasing member 397 may advantageously prevent leakage of the contents ofthe cavity 308 which may be under pressure via the piston 316 while theflowpath forming member 352 is partially penetrated.

Once at least one cam 394 is released and the first end portion of theflowpath forming member 352 extends into the cavity 308 of the primarycontainer 302, and thereby into fluid communication with the contentsthereof, further axial translation of the primary container 302 and thecomponents fixed thereto via the translation mechanism 366 may beprevented. As such, as shown in FIG. 17, further axial translation ofthe piston 316 via the translation mechanism 366 after the first endportion of the flowpath forming member 352 extends into the cavity 308of the primary container 302 and, thereby into fluid communication withthe contents thereof forces the contents through the flowpath formed bythe flowpath forming member 352. As noted above, the flowpath formingmember 352 may be configured to, ultimately, deliver the contents to apatient as a subcutaneous injection or topical application, for example.

FIGS. 19 and 20 illustrate systems and methods for sterilizing thecavity 357 of the chamber portion 356 of the boot 354 and the first endor tip portion of the flowpath forming member 352. In some embodiments,the boot 354 may initially be coupled to the primary container 302 in anunsterile state. Similarly, the first end portion of the flowpathforming member 352 may be inserted into the cavity 357 in an unsterilestate when the system 300 is initially assembled, as shown in FIG. 17for example. In such a configuration of the system 300, a sterilant,such as a gaseous sterilant, may be injected through the pathway of theflowpath forming member 352 and out of the first end portion into thecavity 357. In this way, the pathway of the flowpath forming member 352,the exterior surface of the first end portion of the flowpath formingmember 352 within the cavity 357, and the cavity 357 itself may besterilized in an assembled state of the system 300. The sterilent may beany sterilent effective to sterilize the flowpath forming member 352,the exterior surface of the first end portion of the flowpath formingmember 352 within the cavity 357, and the cavity 357. For example, thesterilent may be ethylene-oxide gas (EtO), vaporized hydrogen peroxide(VHP), nitrogen dioxide (NO2), chlorine dioxide (ClO2), or combinationsthereof.

As shown in FIG. 19, the sterlient may be introduced into the flowpathforming member 352 via a second end portion of the flowpath formingmember 352. The second end portion of the flowpath forming member 352may extend into a seal 321 defining a cavity 323. The seal 321 may bepositioned adjacent an exterior wall or portion 327 of the system 300 ora system or device in which the system 300 is utilized or installed. Inthis way, as shown in FIG. 19, a needle or other insertion member 325may be utilized to extend through the exterior wall 327 and the seal 321and into the cavity 323. The seal 321 may be substantially airtight butfor the flowpath forming member 352 and the insertion member 325. Inthis way, the sterilent may be introduced into the cavity 323 via theinsertion member 325, and therefrom into the flowpath forming member352, as shown by the arrows in FIG. 19. The seal 321 may be configuredto seal any apertures caused by the insertion member 325 and/or theflowpath forming member 352 after the sterilent is introduced.

As illustrated in FIG. 20, the sterilent may flow through the flowpathforming member 352 from the second end to the first end and into thecavity 357 of the chamber portion 256 of the boot 354. The chamberportion 356 may be configured to vent positive pressure out of theopening 358 about the first end portion of the flowpath forming member352 to allow the sterilient to flush out the atmosphere inside theflowpath forming member 352 and within the cavity 357, as shown by thearrows in FIG. 20. The flowpath formed by the flowpath forming member352, the exterior surfaces of the first portion of the flowpath formingmember 352 within the cavity 357, and the cavity 3527 itself may therebybe sterilized after the system 300 is assembled. After sterilization,the sterilent within the flowpath forming member 352 and the cavity 357may be flushed with an inert gas (e.g., nitrogen) to prevent damage tothe contents of the primary container 302 in the same manner as thesterilent was introduced and utilized to flush and sterilize thenon-sterile atmosphere within the flowpath forming member 352 and thecavity 357.

FIGS. 21-23 illustrate an exemplary alternative embodiment of an asepticpiercing system generally indicated by reference numeral 400. Exemplaryaseptic piercing system 400 is similar to the exemplary aseptic piercingsystem 100 described above and illustrated in FIGS. 1-14, the exemplaryaseptic piercing system 200 described above and illustrated in FIGS. 15and 16, and the exemplary aseptic piercing system 300 described aboveand illustrated in FIGS. 17-20, and therefore like reference numeralspreceded by the numeral “4”, as opposed to “1,” “2” or “3,” are used toindicate like functioning elements.

As shown in the pre-activate state in FIG. 21 and the activated state inFIG. 22, the system 400 may utilize a similar primary container 402piercing configuration as the aseptic piercing system 300 describedabove and illustrated in FIGS. 17-20 in that the flowpath forming member452 is driven into and through the septum 414 and into the cavity 408 ofthe primary container 402 and into fluid communication with the contentstherein. One difference between the system 400 and the system 300 isthat the at least one latch or cam portion 494 is a portion of thedriver retainer member 495 rather than the collar 490, as shown in FIGS.21 and 22.

As shown in FIG. 21, the system 400 further differs from the system 300in that the system 400 does not include a boot member that includes achamber portion that forms a cavity for housing the first end portion ofthe flowpath forming member 452 in the pre-activated state of the system300. Rather, the system 400 includes a plug 451 in which the first endportion of the flowpath forming member 452 is positioned in thepre-activated state, as shown in FIG. 21. The plug member 451 mayprovide an aseptic seal about the first end portion of the flowpathforming member 452. In some embodiments, prior to being assembled withthe primary container 402, at least the plug 451 and the first endportion of the flowpath forming member 452 therein may be sterilized(e.g., subjected to radiation) such that the first end portion of theflowpath forming member 452 is sterile and the plug 451 maintains suchsterility. In some embodiments, the plug 451 may be rubber.

Upon activation, the translation mechanism 466 may translate the primarycontainer 402 and the collar 490 such that the at least one activationportion 493 biases the at least one latch 494 of the driver retainer 495to allow the biasing member 497 to drive the driver 498 and the flowpathforming member 452 towards the second end 406 of the primary container402. While being driven towards the second end 406 of the primarycontainer 402, the plug 451 on the first end portion of the flowpathforming member 452 may come into contact with a portion of the collar490, the cap 412, the septum 414 and/or another component coupled orproximate to the second end 406 of the primary container 402 such thatfurther axial translation of the plug 451 is prevented. Once furtheraxial translation of the plug 451 is prevented, the flowpath formingmember 452 may be further axially translated towards the second end 406of the primary container 402 such that the first end portion of theflowpath forming member 452 is driven through the plug 451 and into andthrough the septum 414 and into the cavity 408 of the primary container402 and, thereby into fluid communication of the contents therein.

As illustrated in FIG. 23, the system 400 provides for be partialsterilization before assembly, non-aseptically assembly, andpost-assembly sterilization that does not negatively affect the contentsof the primary container 402. For example, the components forming groupor subassembly A, such as the driver retainer 495, the resilient member497, the driver 498, the first end portion of the flowpath formingmember 452, the plug 451 and/or the collar 490 may be assembled andsterilized as a unit before being assembled with the primary container402 and the component fixed thereto. For example, subassembly A may besubjected to gamma ray or other sterilization techniques that would notbe acceptable in the presence of the contents of the primary container402. As noted above, the plug 451 may maintain the sterilization of thefirst end portion of the flowpath forming member 452. The second end ofthe flowpath forming member 452 may similarly include a plug member toensure complete sterilization of the pathway of the flowpath formingmember 452 and/or the first and second end portions of the flowpathforming member 452.

As described above, the primary container 402 may be sterilized suchthat the contents and cavity 408 are aseptic. As such, sterilesubassembly A can be coupled to the primary container 402 via the neckregion 410 and the collar 490 in a non-sterile environment withaffecting the sterility of the first end portion of the flowpath formingmember 452, as shown in FIG. 23. However, after assembly of thesubassembly A and the primary container 402, the interstitial space Bbetween the primary container 402 and the plug 451 or first end portionof the flowpath forming member 452 may be unsterile, as illustrated inFIG. 23.

To sterilize the interstitial space B, the system 400 may include awindow 432 and window seal 438, as shown in FIG. 23. For example, asdescribed above with respect to the system 100 of FIGS. 1-14, the windowseal 438 may be a permeable material (e.g., Tyvek fabric) that allows asterilent (e.g., a sterilizing gas, such as EtO or VHP) to diffusethrough the window seal 438 and enter the interstitial space B tosterilize the interstitial space B. The permeability of the window seal438 may be so small that pathogens (e.g., viruses, etc.) are unable toenter the interstitial space B after sterilization. As another example,the window seal 438 may be transparent or translucent such that UV lightis able to penetrate through the window seal 438 and into theinterstitial space B to sterilize the interstitial space B.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention. Asused herein, the singular forms “a”, “an” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. It will be further understood that the terms “comprise” (andany form of comprise, such as “comprises” and “comprising”), “have” (andany form of have, such as “has”, and “having”), “include” (and any formof include, such as “includes” and “including”), and “contain” (and anyform of contain, such as “contains” and “containing”) are open-endedlinking verbs. As a result, a method or device that “comprises,” “has,”“includes,” or “contains” one or more steps or elements possesses thoseone or more steps or elements, but is not limited to possessing onlythose one or more steps or elements. Likewise, a step of a method or anelement of a device that “comprises,” “has,” “includes,” or “contains”one or more features possesses those one or more features, but is notlimited to possessing only those one or more features. Furthermore, adevice or structure that is configured in a certain way is configured inat least that way, but may also be configured in ways that are notlisted.

The invention has been described with reference to the preferredembodiments. It will be understood that the architectural andoperational embodiments described herein are exemplary of a plurality ofpossible arrangements to provide the same general features,characteristics, and general system operation. Modifications andalterations will occur to others upon a reading and understanding of thepreceding detailed description. It is intended that the invention beconstrued as including all such modifications and alterations.

1-22. (canceled)
 23. A method of sterilizing an injector having acartridge containing a first fluid, the method comprising: providing asterilant into a cap sealing an opening of the cartridge, while a firstend of a flowpath is disposed within the cap in a first position, tosterilize the first end of flowpath, wherein, while in a secondposition, the first end of the flowpath is in fluid communication withthe first fluid such that the first fluid flows through the flowpathtoward a second end of the flowpath.
 24. The method of claim 23, whereinthe cap includes a first portion including rubber, and a second portionincluding a material permeable to the sterilant.
 25. The method of claim24, wherein the rubber is impermeable to the sterilant.
 26. The methodof claim 24, wherein the sterilant is ethylene oxide (EtO) or nitrogendioxide (NO₂).
 27. The method of claim 24, wherein introducing thesterilant into the cap includes introducing the sterilant from exteriorof the cap, into an interior of the cap, and out of the cap through thesecond portion of the cap.
 28. The method of claim 27, whereinintroducing the sterilant into the cap includes flowing the sterilantfrom the second end of the flowpath, through the flowpath, and into thecap.
 29. The method of claim 23, wherein, before introducing thesterilant into the cap, the method includes assembling the injector in anon-sterile environment or non-aseptic environment.
 30. The method ofclaim 23, wherein the cap includes a cavity.
 31. The method of claim 30,wherein the first end of the flowpath is disposed within the cavitywhile in the first position.
 32. The method of claim 23, wherein, whilein the first position, the first end of the flowpath is not in fluidcommunication with the first fluid contained in the cartridge.
 33. Themethod of claim 23, wherein: the cartridge extends from a first endtoward a second end; a piston movable through the cartridge seals thefirst end of the cartridge; and the cap seals the second end of thecartridge.
 34. The method of claim 33, wherein the piston includes twoor more rounded sealing protrusions that contact an innercircumferential surface of the cartridge.
 35. The method of claim 34,wherein, between adjacent rounded sealing protrusions, the pistonincludes recessed portions that are not in contact with the innercircumferential surface of the cartridge.
 36. The method of claim 33,wherein the piston includes a recess that receives a plunger, and theplunger is coupled to a motor configured to drive the plunger and thepiston from the first end of the cartridge toward the second end of thecartridge.
 37. The method of claim 23, wherein the flowpath isconfigured to subcutaneously inject the first fluid into a patient whenin the second position.
 38. The method of claim 23, wherein: while theflowpath is in the first position, the flowpath is coupled to a biasingmember that is in a compressed state; the biasing member is maintainedin the compressed state by a lock; and the flowpath is configured tomove from the first position to the second position, by altering aconfiguration of the lock to enable expansion of the biasing member fromthe compressed state.
 39. A method of sterilizing an injector having acartridge containing a first fluid, the method comprising: providing asterilant into a cap sealing an opening of the cartridge, while a firstend of a flowpath is disposed within the cap in a first position andbefore fluid communication is established between the flowpath and thefirst fluid, to sterilize the first end of flowpath.
 40. The method ofclaim 39, wherein, while in a second position, the first end of theflowpath is in fluid communication with the first fluid such that thefirst fluid flows through the flowpath toward a second end of theflowpath.
 41. A method of sterilizing an injector having a cartridgecontaining a first fluid, the method comprising: assembling the injectorin a non-sterile environment or non-aseptic environment; after theassembling step, providing a sterilant into a cap sealing an opening ofthe cartridge, while a first end of a flowpath is disposed within thecap in a first position, to sterilize the first end of flowpath, whereinthe cap includes a first portion including rubber, and a second portionincluding a material permeable to the sterilant, wherein, in the firstposition, the first end of the flowpath is not in fluid communicationwith the first fluid contained in the cartridge, and wherein, while in asecond position, the first end of the flowpath is in fluid communicationwith the first fluid such that the first fluid flows through theflowpath toward a second end of the flowpath.
 42. The method of claim41, wherein: the cartridge extends from a first end toward a second end;a piston movable through the cartridge seals the first end of thecartridge; and the cap seals the second end of the cartridge.